In discussing “alternative” medicine it’s impossible not to discuss, at least briefly, placebo effects. Indeed, one of the most common complaints we at SBM voice about clinical trials of alternative medicine is the lack of adequate controls — meaning adequate controls for placebo and nonspecific effects. Just type “acupuncture” in the search box in the upper left hand corner of the blog masthead, and you’ll pull up a number of discussions of acupuncture clinical trials that SBM bloggers have written over the last three years. If you check some of these posts, you’ll find that in nearly every case we spend considerable time and effort discussing whether the placebo or sham control used was adequate, noting that, the better the sham controls, the less likely acupuncture studies are to have a positive result.

Some of the less clueless advocates of “complementary and alternative medicine” (CAM) seem to realize that much of what they do relies on placebo effects. As a result, they tend to argue that what they do is useful and good because it’s “harnessing the placebo effect” for therapeutic purpose. One problem that advocates of SBM (like those of us at SBM who have taken an interest in this topic) tend to have with this argument is that it has always been assumed that a good placebo requires on some level at least some deception of the patient by either saying or implying that he is receiving an active treatment or medicine of some kind. This, we have argued, is a major ethical problem in using placebos in patients, and advocates of placebo medicine appear to agree, because they frequently argue that placebo effects can be harnessed without deception. Indeed, just last week there was an example of this argument plastered all over multiple news outlets and blogs in the form of stories and posts with headlines and titles like:

Except for one, every one of these articles or blog posts discussing a new study in PLoS ONE that purports to have found that placebo effects can be elicited in irritable bowel syndrome (IBS) without deception buys completely into that very thesis. For example, here is an example, taken from the Reuters story about this study:

Placebos can help patients feel better, even if they are fully aware they are taking a sugar pill, researchers reported on Wednesday on an unusual experiment aimed to better understand the “placebo effect.”

Nearly 60 percent of patients with irritable bowel syndrome reported they felt better after knowingly taking placebos twice a day, compared to 35 percent of patients who did not get any new treatment, they report in the Public Library of Science journal PLoS ONE.

“Not only did we make it absolutely clear that these pills had no active ingredient and were made from inert substances, but we actually had ‘placebo’ printed on the bottle,” Ted Kaptchuk of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, who led the study, said in a statement.

As much as I support vaccines, I see the short term consequences. Vaccines can be painful. Kids don’t like them, and parents don’t like seeing their children suffer. That this transient pain is the most common consequence of gaining protection from fatal illnesses seems like a fair trade-off to me. But that’s not the case for every parent.

Today’s post isn’t going to focus on the extremes of the anti-vaccination movement. Rather, it’s going to look at ways to make vaccines less painful and more acceptable to children. The pain of vaccines can lead to anxiety, fear, and even nonadherence with vaccination schedules. Fear of needles and injections is not uncommon, it’s estimated that 10% of the population avoids vaccinations for this reason.

The vaccine schedules are intense. Where I live, the public vaccination schedule specifies seventeen injections of six different products over six visits in the first 18 months of life, plus influenza vaccinations and one-offs like H1N1. That’s a lot of visits, and a lot of tears if a child doesn’t handle them well.

In light of what’s known about the prevalence of needle fears, their potential effect on vaccination adherence (that could persist through adult life), and the possible impact on public health because of unvaccinated individuals, it makes sense to do whatever we can to minimize the pain and discomfort of vaccines, increasing their acceptance to children and their parents. But what works? I’ve personally found Smarties (the real ones) and Dora the Explorer stickers are effective distractions and bribes. But I’m not about to call my n=2 trial good science. Nicely, there’s much more evidence to guide our recommendations.

I gave a lecture last fall on The Vaccine Pseudocontrovery for Oregonians for Science and Reason. There are evidently Oregonians against Science and Reason, hence the title. My Dad went and said it was a good talk. You going to argue with Dad? I think not.

Someone with a handheld camera recorded it, edited it, and put it up on the YouTubes in four parts. The first part is here:

Echinacea purpurea, an ineffective form of treating and preventing colds.

Echinacea continues to be a popular herbal product, used primarily for treating and preventing colds and flus. Sales were estimated at $132 million in the US alone in 2009, an increase of 7% over the previous year. Reports of major negative clinical trials have had only a modest and temporary effect on the popularity and sale of this herb, contradicting claims that the utility of such research is to inform consumers.

In the current issue of the Annals of Internal Medicine there is a new study of Echinacea for the treatment of cold symptoms: “Echinacea for Treating the Common Cold, A Randomized Trial.” I won’t hold out the punchline – the study was completely negative. But let’s put the results of this study into the context of the history of Echinacea and the clinical evidence.

History of Echinacea

Modern proponents of Echinacea frequently cite as support the claim that this plant has been used for centuries by many Native American cultures. This much is well-documented, but what is not clear is what Echinacea was used for. For this there is no clear answer, except that Echinacea was used for 15-20 different and unrelated conditions, from fatigue to snake bites. Let us consider the value of the claim for traditional use of any treatment. (more…)

Myths and misconceptions about cancer abound. Oncologists are frequently criticized for torturing patients by burning, cutting and poisoning without making any real progress in the war against cancer. Siddhartha Mukherjee, an oncologist and cancer researcher, tries to set the record straight with his new book The Emperor of All Maladies: A Biography of Cancer.

It is a unique combination of insightful history, cutting edge science reporting, and vivid stories about the individuals involved: the scientists, the activists, the doctors, and the patients. It is also the story of science itself: how the scientific method works and how it developed, how we learned to randomize, do controlled trials, get informed consent, use statistics appropriately, and how science can go wrong. It is so beautifully written and so informative that when I finished it I went back to page 1 and read the whole thing again to make sure I hadn’t missed anything. I enjoyed it just as much the second time.

Mukherjee says

It will be a story of inventiveness, resilience, and perseverance against what one writer called the most “relentless and insidious enemy” among human diseases. But it will also be a story of hubris, arrogance, paternalism, misperception, false hope, and hype, all leveraged against an illness that was just three decades ago widely touted as being “curable” within a few years. (more…)

On the one hand, I love how epidemiology can look for correlations in huge sample sizes, sample sizes far larger than any that we could ever have access to in clinical trials, randomized or other. I love the ability of epidemiology to generate hypotheses that can be tested in the laboratory and then later in clinical trials. Also, let’s not forget that epidemiology is sometimes the only tool available to us that can answer some questions. Such questions generally involve hypotheses that can’t be tested in a randomized clinical trial because of either ethical concerns or others. A good example of this is the question of whether vaccines cause autism. For obvious ethical reasons, it’s not permissible to perform a randomized clinical trial in which one group of children is vaccinated and one is not, and then outcomes with respect to neurodevelopmental outcomes, such as autism and autism spectrum disorders, are tracked in the two groups. The ethical concern with such a study, of course, is the potential harm that would be likely to come to the unvaccinated control group, children who would be left unprotected against common and postentially deadly communicable diaseases.

On the other hand, epidemiology is one of the messiest of sciences, and epidemiological studies are among the most difficult in all of science to perform truly rigorously. The number of factors that can confound are truly amazing, and as a result, it’s very, very easy for an epidemiological study to detect apparent correlations that are either spurious or appear much stronger than the “true” correlation. There can be confounding factors beneath confounding factors wrapped in more confounding factors, the relationships among which are not always apparent. Not infrequently, a condition can appear to be correlated with, for instance, an environmental factor, but in reality that environmental factor and the condition both correlate with a third, unknown confounder. Worse, epidemiologists know that correlation does not necessarily equal causation, but the general public, for the most part, does not, which is why, when anti-vaccine activists, for instance, point out to a rising autism prevalence and then point out that autism prevalence started rising around the same time the vaccine schedule was expanded, to the average layperson the argument sounds compelling. As a result, the design of an epidemiological study is paramount in order to account for or minimize such factors. That’s why I always said I can’t be an epidemiologist. Even though I was very good at math in college, the statistics still made my brain hurt, and I don’t have the patience for the messiness of trying to account for all the possible confounding factors.

However, for all their strengths and flaws, epidemiological studies are an integral part of science-based medicine. They are used to identify predisposing factors to diseases and conditions, environmental contributors to disease, and adverse reactions to drugs, among many other useful pieces of data. That’s why, from time to time, I like to examine epidemiological studies, particularly if they’re epidemiological studies that are getting a lot of press.

This one crept up on me by surprise. You see, I recorded an interview with D.J. Grothe, President of the James Randi Educational Foundation and host of the podcast For Good Reason back in November. I wasn’t sure when it would appear. Well, it turns out that it popped up on my iTunes podcast feeds sometime over the last few days. (It’s been really busy at work, and I haven’t really been paying attention to podcasts–at least, not until yesterday.)

So, here it is. I haven’t listened to it all yet, but hopefully I explained myself well enough and did credit to my fellow SBM bloggers. DJ is a good interviewer, which means he presses his subjects a bit and sometimes gets them out of their comfort zone.

Osillococcinum

I keep half an eye on the medicine displays in stores when I shop, and this year is the first time I have seen Oscillococcinum being sold. Airborne as been a standard for years, but Airborne has been joined by Oscillococcinum on the shelves. Dumb and dumber. It may be a bad case of confirmation bias, but it seems I am seeing more iocane powder, I mean oscillococcinum, at the stores.

On a recent podcast I was listening to one of the hosts suggested a homeopathic remedy for flu symptoms, and then specifically suggested osillococcinum. This is a technology podcast, the 404, and the hosts are certainly bright, educated people. Why would he suggest osillococcinum? Probably because he unaware of how oh so silly the product is.

In November 2010, the California Department of Consumer Affairs (DCA) finally decided to act responsibly and forbid the prevalent practice of Chinese bloodletting by licensed acupuncturists.

The practice became a concern for the DCA when allegations of unsanitary bloodletting at a California (CA) acupuncture school surfaced.

The incident allegedly occurred during a “doctoral” course for licensed practitioners. The instructor was reportedly demonstrating advanced needling and bloodletting techniques. During the process, he took an arrow-like lancing instrument that is called a “three-edged needle” (三棱针), sharpened it with sandpaper, cleaned it with alcohol, and then asked a student-volunteer to roll a towel around his neck (similar to what is depicted in Image 1). The instructor then cleaned the student’s temporal region with alcohol, and punctured a superficial blood vessel with the arrow-like instrument. The student then held his head over the garbage can, gushing blood for a while.

Images 1 & 2. Chinese bloodletting. Image 1 shows a technique used to bleed the head or the face, where a towel is rolled around the neck to control the arterial pressure. Image 2 shows the practice of “wet cupping.”

The ancient practice of bloodletting, with or without cupping, is still widely used in Chinese medicine to remove “stagnant blood, expel heat, treat high fever, loss of consciousness, convulsion, and pain.”1 The amount of blood let depends on the condition, and the location of the incision. A contemporary book recommends letting a tiny amount from a point adjacent to the thumbnail for a condition described as “wind-heat invasion” of the lung. The symptoms associated with this unscientific nomenclature include chills and fever, sore throat, stuffy or runny nose, and a yellow discharge,2 which could correspond to many respiratory conditions, including the common cold, influenza, pneumonia, etc.(more…)

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1(more…)